Assessment procedures as basis of reimbursement decisions for medical devices- an international overview

Background: Worldwide, various cost and benefit assessment programs for medical devices with different methodology are performed. The aim of this study is highlighting characteristics of some selected countries concerning this matter. Methods: A systematic literature search in Medline, Embase, the Cochrane Library and INAHTA-database was conducted. Additionally, hand searches on websites of country-specific healthcare facilities and single HTA organizations were performed. For the international overview, the countries Australia, the United Kingdom, Canada and the United States of America were selected. Expert consultations were conducted, using a standard questionnaire, supplemented by country-specific questions. Results: Various assessment procedures for medical devices were identified and differences in the influence of cost and benefit assessments on reimbursement decisions were discovered. Because of the heterogeneity of healthcare systems, country-specific programs have different health policy impacts, which complicates a direct comparison. In the selected countries, the methodology for assessing an innovation, the required evidence, patient-relevant outcome parameters and reference methods are determined specifically to the product. To identify relevant medical innovations for benefit assessments, systems of Horizon Scanning are established. Pilot projects for accompanying technology assessments of innovations are promising, but currently not finalized. Conclusion: Benefit assessments and HTA of medical devices become more and more important to ensure the financial sustainability of healthcare systems. Pilot projects for accompanying technology assessment in some healthcare systems are expedited and offer the potential for an adaptation to other countries. Horizon Scanning is a useful method for the identification of promising innovations for subsequent benefit assessment. Rapid HTA can quickly answer limited research questions.